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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling
510(k) Number K121641
Model 9000261
Device Name MINIARC PRO SINGLE-INCISION SLING SYSTEM
Original Applicant
AMERICAN MEDICAL SYSTEMS
10700 bren road west
minnetonka,  MN  55343
Original Contact renee mellum
Regulation Number878.3300
Classification Product Code
PAH  
Date Received06/04/2012
Decision Date 09/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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